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Harnessing the Healthy Gut Microbiota to Cure Patients With Recurrent C. Difficile Infection

A Study Using Synthetic Stool or Pure Cultures of Probiotic Intestinal Bacteria From Healthy Donor Stool That Can be Used as an Enema to Replace the Use of Stool Transplant, for Treatment of Recurrent and Refractory CDI

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01372943
Enrollment
4
Registered
2011-06-14
Start date
2010-01-31
Completion date
2018-08-31
Last updated
2018-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clostridium Difficile Infection

Keywords

Clostridium difficile, recurrent, infection

Brief summary

CDI (Clostridium difficile infection) causes diarrheal illness and can cause colitis which may be fatal. A patient being treated for CDI has a 10-25% chance of developing relapse. Recurrent CDI is on the rise. There are few options available to treat recurrent CDI. Stool transplant (infusing donor stool into the intestine of the recipient), is not very palatable to either patient or medical personnel. The investigators will isolate intestinal bacteria from donor stool and use this purified mixture of donor bacteria instead of stool transplant. The investigators hypothesize that this cleaner mixture of purely isolated intestinal bacteria from a healthy donor would be equally effective as conventional fecal bacteriotherapy, which uses donor stool. The use of this prepared mixture of aerobic and anaerobic organisms, or probiotic approach, is based on the same principle of fecal flora reconstitution. However our approach would provide a more controlled, reproducible, cleaner and more aesthetically acceptable method of administration, and from a patient safety perspective, would also be a safer strategy than using freshly defecated donor fecal matter.

Interventions

BIOLOGICALsynthetic stool or pure cultures of probiotic intestinal bacteria

synthetic stool or pure cultures of probiotic intestinal bacteria from healthy donor stool that can be used as an enema to replace the use of stool transplant, for treatment of recurrent and refractory CDI

Sponsors

The Physicians' Services Incorporated Foundation
CollaboratorOTHER
Queen's University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* patients with recurrent CDI that have failed standard therapy

Exclusion criteria

* critically ill patients

Design outcomes

Primary

MeasureTime frame
number of participants cured of CDI6 months

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026